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GW685698X

Phase 3

Rhinitis, Allergic, Perennial | Small molecule | Other |GSK plc|Last Updated: Jan 19, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials4
Total Enrollment1,547
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00224523Long Term Safety Of GW685698X Via Nasal BiopsyPHASE3 COMPLETED 125 — — Sep 1, 2005Feb 1, 2007Oct 28, 20164 Belgium, Netherlands
NCT00107757Seasonal Allergic Rhinitis In Pediatric SubjectsPHASE3 COMPLETED 576 — — Mar 1, 2005Nov 1, 2005Sep 15, 201665 United States
NCT00108914Perennial Allergic Rhinitis Study In Pediatric SubjectsPHASE3 COMPLETED 558 — — Feb 1, 2005Nov 1, 2005Jan 19, 201766 United States, Argentina +5
NCT00103454A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).PHASE3 COMPLETED 288 — — Jan 1, 2005May 1, 2005Sep 19, 201649 United States, Canada
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Study Endpoints
Primary Endpoints
Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.
Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years.
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.
Secondary Endpoints
No Secondary Outcome Measures
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years.
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
GW685698XDRUG -
mometasone furoateDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion criteria: * History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen. * Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control. Exclusion criteria: *...

Countries:BelgiumNetherlandsUnited StatesArgentinaChileFinlandItalyMexicoSlovakiaCanada
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